Phase IIa Safety and Efficacy Study of SPP635 in Mild to Moderate Hypertension - Full Text View

Sponsored by:	Speedel Pharma Ltd.
Information provided by:	Speedel Pharma Ltd.
ClinicalTrials.gov Identifier:	NCT00376636

Purpose

This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood pressure in patients with mild to moderate hypertension.

Condition	Intervention	Phase
Hypertension	Drug: SPP635 (drug)	Phase II

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Parallel-Design, Four-Week Study to Investigate the Safety and Efficacy of the Oral Renin Inhibitor SPP635 Once Daily in Patients With Mild to Moderate Hypertension

Further study details as provided by Speedel Pharma Ltd.:

Primary Outcome Measures:

Lowering of systolic office blood pressure [ Time Frame: four weeks ]
Lowering of diastolic office blood pressure [ Time Frame: four weeks ]

Secondary Outcome Measures:

Lowering of systolic and diastolic blood pressure (ABPM) [ Time Frame: four weeks ]

Enrollment:	35
Study Start Date:	October 2006
Study Completion Date:	May 2007

Detailed Description:

Renin-Angiotensin system blockade is a well established target for treatment of high blood pressure. Blocking the system at the initial step, however, is a rather new concept that could only be implemented very recently through the availability of novel, oral, renin inhibitors. This study investigates the safety and efficacy of a novel oral renin inhibitor, SPP635.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female patients with mild to moderate hypertension

Exclusion Criteria:

female patients of child-bearing potential or breast-feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376636

Locations

Germany
IKP Bobenheim GmbH
Mannheim, Germany, 68167

Sponsors and Collaborators

Speedel Pharma Ltd.

Investigators

Principal Investigator:

Sybille Baumann-Noss, MD

IKP Bobenheim GmbH

More Information

Study ID Numbers:	SPP635CRD04
Study First Received:	September 14, 2006
Last Updated:	October 29, 2007
ClinicalTrials.gov Identifier:	NCT00376636
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009